Abstract
Aims:
Despite the potential harms of prenatal alcohol exposure, drinking during pregnancy remains a pressing public health concern. Efficacious interventions to reduce alcohol use among pregnant women that can be implemented within prenatal care are urgently needed. This paper describes the development and cultural adaptation of the Safe Start intervention, a brief computer- and nurse-delivered alcohol reduction intervention for pregnant women to be delivered within prenatal care clinics.
Design:
The Safe Start intervention consists of two interactive computer-delivered and three brief nurse-delivered sessions.
Methods:
The format and content of the intervention were designed to be tailored to women’s racial and ethnic backgrounds and drinking goals. A women’s patient advisory group provided feedback to inform the intervention’s development and tailoring of the intervention’s content.
Results:
We overview the theoretical foundations of the Safe Start intervention and the approach to adaptation of intervention material. The format and content of the Safe Start intervention’s computer- and nurse-delivered components are described.
Conclusions:
Interventions to reduce alcohol use during pregnancy that can be integrated within prenatal care are urgently needed. If efficacious in reducing alcohol use, the Safe Start intervention offers the promise of a brief, cost-effective, easily disseminated intervention for pregnant women who consume alcohol.
Keywords: Alcohol, Alcohol-Exposed Pregnancy, Alcohol Reduction Intervention, Computerized Intervention, Multicomponent Intervention, Nurse-Delivered Intervention
INTRODUCTION
Recent research has revealed a notable increase in alcohol use and associated harms following the coronavirus disease 2019 (COVID-19) pandemic (White et al., 2022). This has been especially true for women, whose rate of heavy drinking has increased twice as much as men within the past decade (Patrick et al., 2022). Alcohol consumption has been identified as a leading cause of death and disease and is especially harmful to pregnant women and their babies (White et al., 2022). Current recommendations for pregnant women encourage complete abstinence from alcohol (Bailey & Sokol, 2008). Prenatal alcohol exposure significantly increases the risk of adverse health outcomes such as miscarriage, preterm birth, stillbirth, sudden infant death syndrome, and fetal alcohol spectrum disorder (Centers for Disease Control and Prevention [CDC], 2024; Green et al., 2016; Thompson et al., 2021). According to national data collected from 2018 through 2020, an estimated 11.8%–14.3% of women in the United States reported prenatal alcohol use (Gosdin et al., 2022). Data also indicate an increase in heavy drinking while pregnant, with approximately 5.2% of women reporting binge drinking (Gosdin et al., 2022). In one study, among participants reporting prenatal alcohol use, White women were more likely to engage in such behavior compared with Black women, while Hispanic women were more likely to do so than White women (Thompson et al., 2021).
Given increased rates of alcohol consumption among pregnant women, the CDC identified the need for evidence-based interventions to prevent and reduce alcohol consumption during pregnancy (Luong & Gosdin, 2023). Brief interventions have been endorsed as a “best practice” by the American College of Obstetricians and Gynecologists and the World Health Organization (WHO) to identify and intervene with those at risk for alcohol consumption during pregnancy (American College of Obstetricians and Gynecologists, 2025; Popova et al., 2023). Motivational-based interventions targeting drinking reductions during pregnancy have been found to be efficacious in several clinical trials and have been supported by the National Institute on Alcohol Abuse and Alcoholism as a feasible approach that may minimize patient and resource costs to implement (Handmaker & Wilbourne, 2001; Ingersoll et al., 2013). Although limited physician time has been identified as a barrier in the widespread implementation of brief alcohol reduction interventions during pregnancy (Goplerud et al., 2015; Martino et al., n.d.), there is evidence that nurse-delivered brief motivational interventions may reduce the frequency and quantity of alcohol consumed (Ruben et al., 2021). Additionally, computer-delivered alcohol reduction interventions are cost-effective approaches that can be feasibly delivered within the context of prenatal care; such approaches have demonstrated efficacy to reduce alcohol consumption in general populations and with pregnant women (Tzilos et al., 2011). A meta-analysis highlighted that computer-delivered alcohol reduction interventions are bolstered by integrating interventionist-delivered components that address drinking norms and include goal setting and strategies to maintain reductions in alcohol use (Ingersoll et al., 2013). Thus, there is a need for brief interventions to reduce alcohol use during pregnancy that can be feasibly delivered within the context of ongoing prenatal care. Extant literature points to the promise of motivational-based interventions with delivery via an approach that integrates computer- and nurse-delivered components.
This paper describes the development and cultural adaptation of the Safe Start intervention, a brief computer- and nurse-delivered alcohol reduction intervention for pregnant women. The Safe Start intervention is designed to be delivered within prenatal care appointments via a computer-delivered component coupled with in-person, nurse-delivered motivational enhancement strategies to reduce or eliminate alcohol consumption among pregnant women. The intervention was developed by the research team in collaboration with a women’s patient advisory group. We describe the theoretical foundations and Safe Start intervention development approach, including cultural adaptation strategies. We detail the intervention’s content and format for the computer-delivered modules and the in-person nurse sessions.
METHODS
Intervention Theoretical Foundations
The Safe Start intervention was designed to be feasibly administered within ongoing prenatal care appointments. As such, intervention content was designed to be brief and delivered via computer- and nurse-delivered modules. Importantly, the intervention was developed to provide a brief intervention to pregnant women with potentially problematic drinking rather than pregnant women with more severe alcohol use who may require specialty substance use disorder treatment. The Safe Start intervention was informed by a Screening, Brief Intervention, and Referral to Treatment (SBIRT) approach, as described by the Substance Abuse and Mental Health Service Administration’s (2013) SBIRT Technical Assistance Publication (TAP 33). The computer-delivered component integrated feedback addressing current drinking patterns and social norms regarding alcohol consumption (Black et al., 2016). The nurse-delivered intervention components were designed to reinforce content covered in the computer modules (e.g., establishment of alcohol reduction goals and strategies to achieve identified goals). The Safe Start intervention integrated motivational interviewing techniques into the computer- and nurse-delivered modules, given its efficacy as a brief behavior change intervention to reduce alcohol use (Lundahl et al., 2010). The Safe Start intervention was also informed by our team’s previous development of a brief computer- and clinician-delivered alcohol reduction intervention for women living with human immunodeficiency virus in Russia (Brown et al., 2021).
Cultural Adaptation
The Safe Start intervention was culturally tailored utilizing the Assessment Decision Administration Production Topical experts-Integration Training Testing (ADAPT-ITT) framework to enhance the cultural suitability of the intervention’s content and approach for pregnant women in Texas engaging in prenatal alcohol consumption (Wingood & DiClemente, 2008). The ADAPT-ITT model provides a series of recommended steps to adapt existing evidence-based interventions to be culturally tailored for a different population (Wingood & DiClemente, 2008). The Safe Start intervention was designed to be culturally tailored to women’s racial and ethnic backgrounds. Consistent with the ADAPT-ITT framework, a Women’s Patient Advisory Group was established to inform contextually relevant intervention content, style, design, and format. The Women’s Patient Advisory Group also engaged in theater testing, a pretesting methodology within the ADAPT-ITT approach where the target audience (i.e., pregnant women in Texas) views the intervention to provide feedback to improve the intervention (Wingood & DiClemente, 2008). For example, women provided input regarding the images used in the computer-delivered modules to ensure that images were relatable for women from different racial and ethnic backgrounds. Advisory group members also assisted in culturally adapting the intervention by providing feedback on the Safe Start intervention vignettes, including word choices, situations, and characters. A draft of the computer- and nurse-delivered modules was developed, incorporating the Women’s Patient Advisory Group members’ feedback. Topical experts on the research team then reviewed and iteratively revised the adapted intervention content.
Intervention Approach
The Safe Start intervention was developed for implementation within the context of ongoing prenatal care visits in an obstetrics and gynecology clinic. The intervention is comprised of two brief components: (1) a computer-delivered module (two sessions) and (2) a nurse-delivered session (three sessions). The digital, computer-delivered module is approximately 15 minutes in length and is supplemented with a nurse-delivered session between 5 and 10 minutes in length. Participants complete the initial computer- and nurse-delivered intervention sessions in the first trimester, the second computer- and nurse-delivered session in the second trimester, with a final nurse-delivered session in the third trimester. A summary of the Safe Start intervention is provided in Table 1.
TABLE 1.
Summary of Safe Start Intervention Content
| Intervention Component | Core Content | Sample Vignette |
|---|---|---|
| Nurse-Delivered Sessions (~5–10 Minutes) | ||
| Intervention overview |
|
|
| Alcohol screening and consequences of drinking |
|
|
| Goal setting regarding drinking |
|
|
| Challenges regarding drinking |
|
|
| Strategies for reducing alcohol use |
|
|
| Introduction, establish rapport, and raise subject of alcohol use |
|
|
| Provide feedback |
|
|
| Enhance motivation |
|
|
| Negotiate, advise, and finalize alcohol goal and strategies to reduce drinking |
|
|
Computer-Delivered Alcohol Reduction Intervention Modules: Format
Intervention Programming
The computer-delivered modules were programmed using MediaLab software (MediaLab, 2008). The MediaLab platform allows for interactive intervention components (e.g., survey questions, scored assessments) and presentation of a variety of media, including audio, video, graphics, and images. The intervention was designed for delivery on a laptop, desktop, or tablet computer with audio presented via headphones; the headphones afford additional privacy when reviewing the module. The intervention employed branching and skip logic to direct participants to appropriate content. For example, participants indicated their interest in either an alcohol abstinence or reduction goal and were directed to corresponding content aligned with their identified goal. To culturally tailor the intervention to participants’ racial and ethnic backgrounds, participants were directed to vignettes and images aligned with their racial or ethnic background. For example, Latina participants viewed vignettes with corresponding images featuring pregnant Latina women.
Intervention Narrator
Participants were guided through the computer-delivered content by an intervention narrator named “Sofia.” The narrator was depicted via an image of a clinician (e.g., wearing a white coat, holding a stethoscope) who was a middle-aged woman of color. The narrator provided an overview of the intervention and guided the participant through the intervention content.
Culturally Tailored Vignettes
The intervention included culturally tailored vignettes to provide illustrative examples and make the content more relatable. The vignettes were initially developed by the research team with the Women’s Patient Advisory Group providing feedback on the vignettes’ content and presentation. The vignettes featured two pregnant women struggling with alcohol use during pregnancy (see Table 1 for sample vignettes). The narrator also used the vignettes to illustrate the application of intervention skills and to provide normative feedback regarding alcohol use. The names of the women depicted in the vignettes were tailored to align with the race/ethnicity of the participant (Black, White, or Hispanic/Latine) as advised by the Women’s Patient Advisory Group. Participants who identified as Asian, Indigenous, or other racial background were presented with vignettes depicting White women.
Culturally Tailored Images and Infographics
The intervention integrated culturally appropriate images for the narrator and vignette characters. The research team identified candidate images, and the Women’s Patient Advisory Group reviewed the images and provided input that informed the selection of final images. The images of women depicted in the vignettes were tailored to match the race/ethnicity of the participant (Black, White, or Hispanic/Latine). Generally, the images were selected to be authentic presentations of pregnant women who receive prenatal care at the clinic. Additional infographics were created to illustrate intervention content (e.g., symptoms of fetal alcohol spectrum disorder, strategies to reduce or abstain from alcohol, standardized drinks for different types of alcohol).
Individually Tailored Exercises and Feedback
The computerized component included interactive activities to allow participants to practice applying intervention material. For example, participants responded to questions to identify their alcohol reduction goals and develop skills to address personal challenges to reduce drinking. Participants also completed an assessment of recent alcohol consumption and were provided with feedback regarding their drinking including the potential maternal and fetal risks for drinking during pregnancy.
Computer-Delivered Alcohol Reduction Intervention Modules: Content
The first computer-delivered module included the following components: (a) Safe Start intervention overview; (b) psychoeducation regarding the consequences of drinking during pregnancy; (c) assessment of recent drinking patterns and provision of normative feedback; (d) identification of a personal alcohol reduction goal; (e) content to enhance motivation to reduce drinking; and (f) strategies to reduce drinking and address personal challenges related to drinking. The second computer-delivered module reinforced content covered in the initial session and sought to further enhance participants’ motivation and skills to reduce their drinking to meet their identified alcohol reduction goal.
Safe Start Intervention Overview
The intervention narrator provided an overview of the Safe Start intervention’s computer- and nurse-delivered components. The goals of the intervention were introduced, and the narrator highlighted that participants would be hearing about other pregnant women’s experiences throughout the intervention (i.e., via the vignettes).
Psychoeducation on the Consequences of Drinking
The intervention provided psychoeducation regarding maternal and fetal consequences of drinking during pregnancy. The narrator delivered the psychoeducation material that was accompanied by illustrative infographic images (e.g., long-term negative health outcomes associated with drinking, harmful effects of alcohol on fetal development). The content stressed that there was no safe level of alcohol consumption during pregnancy. Additionally, content to highlight the potential benefits for alcohol reduction or abstinence was provided (e.g., mood enhancement, commitment to having a healthy baby).
Assessment of Alcohol Consumption and Feedback
Participants completed the alcohol subscale of the WHO’s Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) regarding their drinking for the 3 months before their pregnancy (WHO, 2002). A graphic displaying standardized drink sizes was provided for different types of alcohol. The ASSIST assesses the severity of drinking using validated cutoff scores corresponding to “low,” “moderate,” and “severe” risk. Participants’ responses were scored, and they received personalized feedback based on their alcohol severity level.
Establishing a Personal Goal for Alcohol Consumption
Participants were asked to reflect on their current alcohol consumption and whether they were interested in (1) reducing their drinking (harm reduction goal) or (2) stopping drinking completely (abstinence goal). Participants who chose a harm reduction goal were then prompted to determine the number of days they wished to consume alcohol during the next month along with the corresponding number of drinks per occasion. For both goals, participants were reminded that there was no safe level of drinking during pregnancy.
Enhancing Motivation for Identified Alcohol Goal
Motivational interviewing strategies were employed to bolster participants’ motivation to achieve their identified goal. For example, participants were asked to rate the importance of their goal (i.e., “How important from 0 to 10 is your identified drinking goal?”) and to identify personal reasons behind their goal to abstain or reduce alcohol consumption.
Identifying Drinking Challenges and Strategies to Reduce Alcohol Consumption
Participants were asked to identify people, places, emotional states, or situations that may be high risk for engaging in alcohol consumption. The activity drew upon principles of functional analysis through the identification of high-risk antecedent factors associated with alcohol use, patterns of alcohol use, and corresponding reinforcers of drinking (Morgan, 2003). Next, participants were provided with strategies to support their alcohol goal. Strategies included avoiding high-risk drinking situations, developing approaches to limit access to alcohol, making alternative plans for activities where alcohol is not present, and seeking additional services. Strategies to navigate alcohol cravings included relaxation skills, delayed drinking, engaging in a distracting activity, monitoring alcohol use (i.e., substance use diary), and enhancing personal motivation by considering personal reasons to not drink. Assertive communication and refusal skills were also demonstrated as an approach to decline alcohol use in high-risk situations.
Nurse-Delivered Alcohol Reduction Intervention Sessions: Format
The three nurse-delivered intervention sessions were designed to be approximately 5–10 minutes in length. A nurse-delivered intervention session is delivered immediately after each of the two computer sessions in the first and second trimesters, respectively; the third nurse-delivered intervention session is delivered alone during the third trimester. The sessions were developed to be delivered by nursing staff within prenatal care who have minimal experience delivering motivational interviewing or substance use-focused interventions. An intervention guide provides scripted content to guide the delivery of the intervention.
Nurse-Delivered Alcohol Reduction Intervention Session: Content
The nurse-delivered component serves to reinforce content presented in the computerized portion of the intervention. The nurse-delivered sessions leverage motivational interviewing techniques via scripted material in a session guide. Each session is divided into four brief sections. First, nurses work to establish rapport with participants and raise the subject of discussing participants’ alcohol use. Next, nurses solicit participants’ personal challenges related to reducing or abstaining from alcohol use during pregnancy. Third, nurses ask participants to reiterate the alcohol goal they established during the computerized intervention (i.e., abstinence vs. alcohol reduction goal). Using motivational interviewing strategies, nurses then seek to enhance participants’ motivation for their established goal. Specifically, nurses assess the participant’s confidence level to achieve their identified drinking goal (from 0 to 10) and seek to elicit factors that would bolster the participant’s confidence to achieve the identified goal. Last, the nurse works collaboratively with participants to identify strategies that would be helpful in reaching their alcohol goal. An opportunity to practice assertive communication skills with the nurse is provided. Last, nurses and participants collaboratively complete a goal worksheet that includes both the participant’s alcohol goal and identified strategies to enhance their success in reaching their goal. A copy of the goal worksheet is provided to participants and is also retained by the nursing staff to revisit in the subsequent nurse-delivered session.
DISCUSSION
Consistent with nationwide increases in alcohol consumption, women have been found to consume more alcohol on average. Concurrently, a spike in alcohol consumption in pregnant women has been observed after the COVID-19 pandemic (Ruyak et al., 2023). Alcohol has been found to be the most used substance during pregnancy (Kar et al., 2021). Several factors have been associated with drinking while pregnant, including age, education, marital status, and inconsistent ability to access health care (Gosdin et al., 2022). For example, data indicate that younger women may have less knowledge about the adverse effects of alcohol, with more tolerant attitudes toward drinking and may also have a higher alcohol intake during pregnancy (Walker et al., 2005). Given the adverse health outcomes to both mothers and babies coupled with increased alcohol consumption during pregnancy, the CDC recommends alcohol screening and brief interventions tailored for pregnant women in health care settings (Gosdin et al., 2022).
Previous research points to the potential acceptability and efficacy of brief, computer-delivered alcohol reduction interventions that can be delivered in health care settings (Ondersma et al., 2012). Further, interventions integrating in-person motivational enhancement strategies have also been efficacious in reducing alcohol consumption among pregnant women (Ingersoll et al., 2013). Thus, we sought to develop a culturally tailored alcohol reduction intervention that couples brief computer- and nurse-delivered components that could be feasibly delivered within the context of ongoing prenatal care appointments.
Cultural tailoring of interventions may increase intervention adoption by health care providers in clinical settings (Wingood & DiClemente, 2008). The ADAPT-ITT model provided the framework to adapt the intervention to be culturally relevant for pregnant women consuming alcohol. The ADAPT-ITT framework provided a systematic approach to modify existing evidence-based interventions to an interactive, hybrid format. The multicomponent Safe Start intervention is currently being evaluated for efficacy and acceptability (NCT05766761) to gather data on its impact on alcohol use among pregnant women. If efficacious, future research should consider implementation strategies to enhance the deployment of the intervention in other prenatal care clinics.
Acknowledgments
This study was funded by a grant from the National Institute of Alcohol Abuse and Alcoholism (U01AA030187: DiClemente, PI) as part of the Collaborative Initiative on Fetal Alcohol Spectrum Disorders.
Footnotes
The authors report no conflicts of interest.
Additional information about the Collaborative Initiative on Fetal Alcohol Spectrum Disorders is available on www.cifasd.org. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Contributor Information
Jennifer L. Brown, Department of Psychological Sciences, Purdue University, West Lafayette, Indiana..
Sofia Rubi, Department of Psychological Sciences, Purdue University, West Lafayette, Indiana..
Gina M. Wingood, Department of Sociomedical Sciences, Mailman School of Public Health, Columbia University, New York, New York..
Ariadna Capasso, Health Resources in Action, Boston, Massachusetts..
Yolanda R. Villarreal, Department of Family & Community Medicine, UT Health Houston McGovern Medical School, Houston, Texas..
Angela L. Stotts, Department of Family & Community Medicine, UT Health Houston McGovern Medical School, Houston, Texas..
Ralph J. DiClemente, Department of Social & Behavioral Sciences, School of Global Public Health, New York University, New York..
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